Evaluation of ZestiVits in Children and Adults on a Ketogenic or Restricted Therapeutic Diet

Vitaflo International, Ltd15 enrolled

Overview

A study to evaluate the acceptability of ZestiVits; a new vitamin, mineral and trace element supplement for children aged 11 years and over and adults on a ketogenic or restricted therapeutic diet with regard to product tolerance, palatability and compliance.

To evaluate the gastrointestinal tolerance, palatability and compliance of ZestiVits in a seven-day period for 15 subjects aged 11 years and over following a ketogenic or restricted therapeutic diet. * Qualitative assessments from subject questionnaires that allow evaluation of the acceptability and ease of use of the study product. * Collection of daily data about the gastro-intestinal tolerance of the study product. * Collection of daily data about compliance with the study product i.e. actual versus prescribed intake. * Improve quality of life by increasing range of products available for use in a ketogenic or restricted therapeutic diet.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Deficiency of Micronutrients

Interventions

ZestiVitsDIETARY_SUPPLEMENT

The study product is a low-carbohydrate, orange flavour, vitamin, mineral and trace element (micronutrient) supplement for use in ketogenic and restricted therapeutic diets, for children aged from 11 years of age and adults. The recommended dosage of the study product for each subject will be determined and prescribed by a dietitian. This will be based on individual requirements for micronutrient supplementation.

Eligibility

Sex: ALLMin age: 11 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of condition requiring a ketogenic or restrictive therapeutic diet 2. On a ketogenic or restricted therapeutic diet with good compliance 3. Aged 11 years and over 4. Has a requirement for a micronutrient supplement 5. Written informed consent by subject or parent/carer Exclusion Criteria: 1. Participants aged less than 11 years 2. Use of additional micronutrient supplements during the study period unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file)

Locations (3)

Bristol Royal Hospital for Children

Bristol, Avon, United Kingdom

Salford Royal NHS Foundation Trust

Salford, Greater Manchester, United Kingdom

Leeds Children's Hospital

Leeds, West Yorkshire, United Kingdom

Outcomes

Primary Outcomes

Palatability via qualitative assessments from a subject questionnaire

Qualitative outcome measures will be described in a narrative summarising the study outcomes

Time frame: 7 days

Gastrointestinal tolerance via qualitative assessments from a subject questionnaire

Qualitative outcome measures will be described in a narrative summarising the study outcomes

Time frame: 7 days

Patient compliance via qualitative assessments from a subject questionnaire

Qualitative outcome measures will be described in a narrative summarising the study outcomes

Time frame: 7 days

Ease of use of product via qualitative assessments from a subject questionnaire

Qualitative outcome measures will be described in a narrative summarising the study outcomes

Time frame: 7 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.